MAUDE Adverse Event Report: LUTONIX, INC LUTONIX 035AV DRUG COATED PTA DILATION CATHETER; DRUG COATED BALLOON PTA CATHETER

Model Number	9010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Restenosis (4576)
Date of Event	04/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H10: d4 (expiry date: 06/2023).H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : device not returned.
Event or Problem Description
It was reported through the results of a clinical trial that two months and eight days post index procedure using a drug-coated balloon catheter in the cephalic vein, the subject developed a serious adverse event of recurrent stenosis on target lesion cephalic vein which required an additional arteriovenous access circuit reintervention.It was further reported that two months and sixteen days post index procedure, the target lesion in the right forearm had an eighty-two percent initial stenosis and ten percent final residual stenosis.It was also reported that five months and twenty-two days post index procedure, the subject developed a serious adverse event of two stenosis one in cephalic vein and other on subclavian vein which required an additional arteriovenous access circuit reintervention.Moreover, six months and fifteen days post index procedure, the target lesion in the cephalic vein had an eighty percent initial stenosis and twenty-five percent final residual stenosis.Furthermore, the target lesion in the cephalic vein was treated with standard percutaneous transluminous angioplasty procedure and other drug coated balloon catheter.The re-intervention was successful, no new access created, and the outcome was resolved.Reportedly, there have been no documented device deficiencies reported for this subject to date.The current status of the patient is unknown.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.Based upon the available information, the definitive root cause is unknown.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H11: section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : device not returned.
Event or Problem Description
It was reported through the results of a clinical trial that two months and eight days post an index procedure completion using a drug-coated balloon catheter in the cephalic vein, the subject developed a serious adverse event of anastomotic stenosis on the cephalic vein which required an additional arteriovenous access circuit reintervention.It was further reported that two months and sixteen days post an index procedure completion, the target lesion in the right forearm had an eighty-two percent initial stenosis and ten percent final residual stenosis.It was also reported that five months and twenty-two days post an index procedure completion, the subject developed a serious adverse event of two stenosis one in the cephalic vein and the other on the subclavian vein which required an additional arteriovenous access circuit reintervention.Moreover, six months and fifteen days post index procedure, the target lesion in the cephalic vein had an eighty percent initial stenosis and twenty-five percent final residual stenosis.Furthermore, ten months and eight days post an index procedure completion, the subject developed a serious adverse event of recurrent stenosis on the cephalic vein.Additionally, ten months and twenty-six days post an index procedure completion, the target lesion in the cephalic vein had a sixty-seven percent initial stenosis and twenty-seven percent final residual stenosis.However, the target lesion in the cephalic vein was treated with standard percutaneous transluminal balloon angioplasty procedure and other drug coated balloon catheter.The re-intervention was successful, no new access created, and the outcome was resolved.Reportedly, there have been no documented device deficiencies reported for this subject to date.The current status of the patient is unknown.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.Based upon the available information, the definitive root cause is unknown.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H11: section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported through the results of a clinical trial that two months and eight days post an index procedure completion using a drug-coated balloon catheter in the cephalic vein, the subject developed a serious adverse event of anastomotic stenosis on the cephalic vein due to decreased access blood flow which required an arteriovenous access circuit reintervention.Reportedly, standard percutaneous transluminal balloon angioplasty and drug coated balloon catheter procedures were performed to treat decreased access blood flow.The treatment re-intervention was successful, no new access created, and the outcome of the serious adverse event was resolved.It was further reported that five months and twenty-two days post an index procedure completion, the subject developed a serious adverse event of two stenosis one in the cephalic vein and the other on the subclavian vein due to decreased access blood flow which required an arteriovenous access circuit reintervention.Reportedly, standard percutaneous transluminal balloon angioplasty and drug coated balloon catheter procedures were performed to treat decreased access blood flow.The treatment re-intervention was successful, no new access created, and the outcome of the serious adverse event was resolved.Furthermore, ten months and eight days post an index procedure completion, the subject developed a serious adverse event of recurrent stenosis on the cephalic vein due to decreased access blood flow which required an arteriovenous access circuit reintervention.Reportedly, standard percutaneous transluminal balloon angioplasty and drug coated balloon catheter procedures were performed to treat decreased access blood flow.The treatment re-intervention was successful, no new access created, and the outcome of the serious was resolved.Reportedly, there have been no documented device deficiencies reported for this subject to date.The current status of the patient is unknown.
Event or Problem Description
It was reported through the results of a clinical trial that two months and eight days post an index procedure completion using a drug-coated balloon catheter in the cephalic vein, the subject had serious adverse event of anastomotic stenosis on the cephalic vein which required an arteriovenous access circuit reintervention.It was further reported that two months and sixteen days after index procedure, standard percutaneous transluminal angioplasty and drug coated balloon catheter was used to treat cephalic vein restenosis.Treatment re-intervention was successful, no new access created, and the outcome of the serious adverse event was resolved.It was also reported that five months and twenty-two days after index procedure, the subject had serious adverse event of two stenosis one in the cephalic vein and the other on the subclavian vein which required an arteriovenous access circuit reintervention.Furthermore, six months and fifteen days after index procedure, standard percutaneous transluminal angioplasty and drug coated balloon catheter was used to treat cephalic vein restenosis.Treatment re-intervention was successful, no new access created, and the outcome of the serious adverse event was resolved.Additionally, ten months and eight days after index procedure, the subject had serious adverse event of recurrent stenosis on the cephalic vein which required an arteriovenous access circuit reintervention.Evidently, ten months and twenty-six days after index procedure, standard percutaneous transluminal balloon angioplasty and drug coated balloon catheter was used to treat cephalic vein restenosis.Treatment re-intervention was successful, no new access created, and the outcome of the serious adverse event was resolved.Moreover, one year, four months, and fifteen days after index procedure, the subject had serious adverse event of stenosis of the cephalic vein and the cephalic arch which required an arteriovenous access circuit reintervention.Apparently, one year, four months, and twenty-one days after index procedure, standard percutaneous transluminal angioplasty was performed to treat cephalic vein restenosis.Treatment re-intervention was successful, no new access created, and the outcome of the serious adverse event was resolved.In addition, one year, five months, and twenty-seven days after index procedure, the subject had serious adverse event of recurrent stenosis on cephalic vein which required an arteriovenous access circuit re-intervention.Evidently, one year, six months, and eleven days after index procedure, standard percutaneous transluminal angioplasty was performed to treat cephalic vein restenosis.Treatment re-intervention was successful, no new access created, and the outcome of the serious adverse event was resolved.Additionally, one year, six months, and twenty-six days after index procedure, the subject had serious adverse event of recurrent stenosis on cephalic vein which required an arteriovenous access circuit reintervention.Evidently, one year, seven months, and eight days after index procedure, standard percutaneous transluminal angioplasty and drug-coated balloon catheter was used to treat cephalic vein restenosis.Treatment re-intervention was successful, no new access created, and the outcome of the serious adverse event was resolved.Reportedly, there have been no documented device deficiencies reported for this subject to date.The current status of the patient is unknown.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.Based upon the available information, the definitive root cause is unknown.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H11: section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: LUTONIX 035AV DRUG COATED PTA DILATION CATHETER
• Common Device Name: DRUG COATED BALLOON PTA CATHETER
• Manufacturer (Section D): LUTONIX, INC; 9409 science center dr; new hope MN 55428
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 17894225
• Report Number: 3006513822-2023-00038
• Device Sequence Number: 17011894
• Product Code: PRC
• UDI-Device Identifier: 00801741135408
• UDI-Public: (01)00801741135408(11)200713(17)230611(10)GFET0856
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P170003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/11/2023
• Device Model Number: 9010
• Device Catalogue Number: LX3575680V
• Device Lot Number: GFET0856
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/13/2023
• Supplement Date Received by Manufacturer: 02/28/2024; 05/14/2024; 10/18/2024
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 03/02/2024; 05/20/2024; 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/13/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White